NIH Director’s Blog, 10 November 2015 In recent years, there’s been a lot of talk about…

Data Sharing and Disclosure Initiatives Shape Clinical Research

Appliedclinicaltrialsonline: Jul 3, 2013

Transparency and collaboration are prominent themes in the biopharmaceutical R&D community, with proposals multiplying to expand access to clinical trial information and to pool pre-competitive data to build research standards and tools. While activists talk about uncovering “hidden” safety information, the real benefits of data disclosure lie in developing more targeted and informed research protocols and avoiding studies likely to fail.

On the regulatory front, the European Medicines Agency (EMA) seeks to publish clinical trial data submitted in market applications, a policy raising strong objections from pharma. The Food and Drug Administration has proposed a more limited disclosure policy that would allow outside access to pooled, de-identified and masked data from multiple clinical and preclinical studies to help identify new clinical trial endpoints and safety issues. In a June 4, 2013 Federal Register notice, the agency seeks comments on its plan, noting that it won’t release confidential information or trade secrets from product applications. Read More